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Automatic Hybrid Capture System
EUDAMEDClass A (EU MDR)
Ref HB-304CModel HB-104CRef HB-314C
Identity
- Trade Name
- Automatic Hybrid Capture System EUDAMED
- Device Name
- Automatic Hybrid Capture System EUDAMED
- Model / Reference
- HB-104C EUDAMEDHB-304C EUDAMEDHB-314C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973873149036 EUDAMED06973873149043 EUDAMED06973873149029 EUDAMED
- Basic UDI-DI
- 697387314HBCTQ EUDAMED
- Direct Marketing DI
- 06973873149036 EUDAMED06973873149043 EUDAMED06973873149029 EUDAMED
- EMDN Code
- W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Hybrid Capture System by Hangzhou Dalton BioSciences, Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697387314HBCTQ | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Dalton BioSciences, Ltd.
- EUDAMED SRN
- CN-MF-000036196
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (3)
- EUDAMED ff5f48ca-0be5-447f-954d-91f6611a0b19 61 fields · synced Sep 17, 2026
- EUDAMED 03d28e74-006d-4b2f-9027-ee8009c4771b 61 fields · synced May 18, 2026
- EUDAMED 959f43d0-8776-4310-bc55-643c7e391ff0 61 fields · synced May 18, 2026